Medical Director, Hepatitis B
Function: Medical Affairs / Clinical Development
Reporting To: Chief Medical Officer or Designated Medical Leadership
Therapeutic Area: Hepatitis B
Location: Flexible, based on candidate qualifications and business needs
Position Overview
We are seeking a clinically experienced, scientifically rigorous
Medical Director with deep Hepatitis B expertise to provide medical monitoring and clinical oversight for ongoing and planned clinical development programs.
This individual will play a critical role in ensuring patient safety, clinical data integrity, and appropriate medical decision-making throughout clinical trials. The Medical Director will work closely with Clinical Operations, Clinical Development, Pharmacovigilance, Regulatory Affairs, and external investigators to support the safe and effective execution of clinical studies.
The ideal candidate will bring strong experience in medical monitoring, clinical trial oversight, safety review, and the interpretation of clinical data, with the ability to make sound medical judgments in a complex therapeutic area. Experience in Hepatitis B clinical development is essential.
Key Responsibilities
Medical Monitoring and Patient Safety
- Provide medical monitoring and ongoing medical oversight of Hepatitis B clinical trials, ensuring participant safety and adherence to study protocols.
- Review clinical data, laboratory results, adverse events, serious adverse events, and other relevant safety information to identify emerging risks and clinically significant trends.
- Assess individual patient cases and provide timely medical guidance regarding eligibility, treatment continuation, dose modifications, treatment interruptions, and discontinuation, as appropriate under study protocols.
- Review and interpret liver function tests, virologic markers, and other clinically relevant parameters associated with Hepatitis B and investigational treatment.
- Evaluate potential drug-related toxicities, disease-related complications, and clinically meaningful changes in patient status.
- Support medical review of safety signals and collaborate with Pharmacovigilance to ensure appropriate escalation, documentation, and follow-up.
- Provide medical input into safety management plans, risk mitigation strategies, and clinical trial protocols.
Clinical Trial Medical Oversight
- Provide medical leadership throughout the planning, initiation, conduct, and completion of Hepatitis B clinical studies.
- Review study protocols, amendments, informed consent documents, investigator brochures, and other clinical development materials from a medical and scientific perspective.
- Ensure that clinical study designs, eligibility criteria, safety monitoring plans, and endpoints are medically appropriate and aligned with the objectives of the development program.
- Support the medical review of clinical data, including identification of data inconsistencies, clinically significant trends, and issues requiring further investigation.
- Collaborate with Clinical Operations to address medical questions from investigators and clinical research sites.
- Provide medical guidance on protocol deviations, eligibility exceptions, complex clinical scenarios, and other issues requiring physician-level or advanced clinical judgment.
- Contribute to medical review plans, data review processes, and clinical study oversight procedures.
Hepatitis B Therapeutic Expertise
- Apply a strong understanding of Hepatitis B virology, disease pathophysiology, natural history, current standards of care, and emerging therapeutic approaches.
- Interpret relevant virologic and clinical biomarkers, including HBV DNA, HBsAg, HBeAg where applicable, liver enzymes, and other study-specific endpoints.
- Evaluate clinically meaningful changes in viral activity, liver function, and disease status during investigational treatment.
- Contribute to the assessment of treatment-related risks, potential antiviral activity, and the clinical relevance of emerging data.
- Provide scientific and medical input into clinical development strategy, study design, endpoint selection, and interpretation of results.
- Stay current on developments in Hepatitis B research, including functional cure strategies, Client antiviral approaches, and emerging therapeutic modalities.
Cross-Functional Collaboration
- Partner with Clinical Development, Clinical Operations, Pharmacovigilance, Biostatistics, Data Management, and Regulatory Affairs to support high-quality clinical trial execution.
- Work closely with investigators and study teams to resolve complex medical questions and support consistent application of study protocols.
- Participate in safety review meetings, data review meetings, and clinical development team discussions.
- Support preparation and medical review of clinical study reports, regulatory submissions, safety updates, and other clinical documentation.
- Communicate medical risks, emerging safety findings, and key clinical observations to relevant stakeholders and leadership.
- Contribute to the continuous improvement of medical monitoring processes and clinical oversight practices.
Investigator and Site Support
- Serve as a medical point of contact for investigators and clinical research sites participating in Hepatitis B studies.
- Provide timely, scientifically sound responses to medical inquiries arising during clinical trial conduct.
- Support investigator training and education on study protocols, safety considerations, and relevant Hepatitis B disease characteristics.
- Help ensure that medical decisions are appropriately documented, consistent with protocol requirements, and aligned with patient safety priorities.
Required Qualifications
- MD, DO, or equivalent medical degree required.
- Significant clinical or pharmaceutical industry experience in clinical development, medical monitoring, or clinical trial medical oversight.
- Substantial Hepatitis B experience required , including a strong understanding of HBV disease biology, virology, treatment approaches, and clinical trial endpoints.
- Demonstrated experience reviewing clinical trial safety data and making or supporting medical assessments of adverse events, laboratory abnormalities, and patient-level clinical issues.
- Experience with clinical trial protocols, safety monitoring plans, eligibility criteria, and clinical study documentation.
- Ability to interpret complex clinical and laboratory data and identify potential safety concerns or clinically meaningful trends.
- Strong judgment, attention to detail, communication skills, and ability to work effectively across multidisciplinary teams.
- Familiarity with Good Clinical Practice (GCP), applicable clinical trial regulations, and patient safety requirements.
Preferred Qualifications
- Prior pharmaceutical or biotechnology industry experience supporting Phase I–III clinical trials.
- Direct experience serving as a medical monitor or Medical Director for Hepatitis B or other liver disease clinical development programs.
- Experience with investigational therapies targeting HBV, including Client antiviral or functional cure approaches.
- Experience in clinical safety review, signal evaluation, and collaboration with Pharmacovigilance.
- Familiarity with clinical trial data review systems, safety databases, and risk-based medical monitoring approaches.
- Experience supporting regulatory interactions and preparation of clinical development documentation.
- Experience working with international investigators, global study teams, and clinical research sites.
Key Competencies
- Medical judgment: Makes rigorous, timely, and well-documented clinical assessments.
- Patient safety focus: Identifies potential risks early and ensures appropriate escalation and follow-up.
- Hepatitis B expertise: Understands disease-specific clinical considerations, biomarkers, treatment risks, and emerging therapeutic approaches.
- Clinical data interpretation: Distinguishes clinically meaningful findings from routine data variability.
- Cross-functional leadership: Works effectively across clinical, safety, operational, and regulatory teams.
- Scientific communication: Explains complex medical issues clearly to investigators, internal stakeholders, and leadership.
- Operational execution: Balances timely study support with thorough medical review and documentation.
Measures of Success
- Consistent, high-quality medical monitoring across assigned Hepatitis B clinical studies.
- Timely identification, assessment, and escalation of clinically significant safety issues.
- Effective medical review of patient-level data, laboratory results, and emerging clinical trends.
- Strong collaboration with investigators and internal clinical development teams.
- High-quality medical input into study protocols, safety documentation, and clinical development decisions.
- Adherence to applicable GCP standards, regulatory requirements, and patient safety procedures.
Ideal Candidate Profile
The ideal candidate is a physician with deep Hepatitis B expertise and hands-on experience in clinical trial medical monitoring and oversight. They combine strong clinical judgment with the ability to interpret complex safety and efficacy data, guide medical decision-making, and collaborate effectively with investigators and cross-functional teams.
This individual will be comfortable operating in a dynamic biotechnology environment, taking ownership of medical review activities, and helping advance Hepatitis B clinical development programs while maintaining the highest standards of patient safety and scientific rigor.
The defining requirement is a physician-level medical leader with meaningful Hepatitis B expertise and demonstrated capability in clinical trial medical monitoring, safety assessment, and ongoing medical oversight.
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.
